The present invention generally relates to introducers and introducing assemblies. Specifically, it relates to a safety introducer with a safety needle.
Introducer devices provide for access to the venous system and are employed for inserting medical devices such as catheters, guidewires, leads, infusion ports, dialysis ports, dialysis catheters, and others. A typical procedure for gaining access to the central venous system or the arterial system with an introducer is the Seldinger Introduction Method. The Seldinger Method provides for insertion of a needle into the vasculature of a patient. Once the needle is in the vessel, the physician aspirates the needle to assure that the needle is in the vessel, and to draw out air present in the bore of the needle. The syringe is removed and discarded. A guide wire is inserted through the needle, and the needle is removed over the guide wire. The introducer, which includes a dilator and the sheath, is placed over the guidewire and inserted into the vessel. With the introducer and wire guide in the vessel, the dilator and wire guide are removed leaving only the sheath in the vessel. The desired medical device is implanted through the bore of the sheath. The sheath is optionally removed from the medical device.
Any time a needle is used it can cause transmission of various pathogens, most notably the Human Inmune Virus (HIV), due to an accidental needle stick of an uninfected person after the needle is withdrawn from the patient, or due to re-use of a needle. Furthermore, the Seldinger Method requires numerous steps, resulting in extra costs, potential trauma, and/or pain for a patient.
Accordingly, what is needed is an introducer and dilator which can eliminate needle re-use or inadvertent needle sticks. What is also needed is an introducer assembly which does not distract or interfere with the implantation process.
An introducing apparatus is provided which includes an elongate tubular sheath extending from a sheath proximal end to a sheath distal end. The sheath has a bore sized to receive a dilator therethrough, and a bore sized to receive medical instruments therethrough. The dilator extends from a dilator proximal end to a dilator distal end. The introducing apparatus further includes a needle disposed within the dilator, where the needle is retractably coupled with the dilator with a needle retraction mechanism. The needle extends from a needle proximal end to a needle distal end and has an intermediate portion therebetween. The distal end of the needle extends out of the dilator distal end in a first position, and the needle distal end is retracted within the dilator distal end in a second position. At least a portion of the needle is flexible. The needle distal end is optionally echogenic.
Several options for the introducing apparatus are as follows. For example, in one option, the sheath is separable without damage to an instrument inserted therethrough. In another option, the needle distal end is more flexible than the dilator. In yet another option, the needle distal end has the same or less of flexibility as the dilator. A portion of the intermediate portion and the needle distal end are more flexible than the dilator in another option. In another option, the intermediate portion of the needle is a flexible coil. In yet another option, the intermediate portion and the needle distal end are flexible, and the needle is formed of a unitary structure of nitinol.
Further options include an air permeable filter and/or a valve coupled with the sheath. In another option, the dilator includes a catch sized and shaped to prevent re-extension of the needle. In yet another option, the introducing apparatus includes a locking mechanism configured to temporarily lock the sheath with the dilator. The dilator, in another option, further includes a blood flashback chamber. In one option, the intermediate portion of the dilator is further defined by first and second dilator intermediate portions, and the dilator first intermediate portion has a greater outer diameter than an outer diameter of the dilator distal end, and the dilator second intermediate portion has a greater outer diameter than the outer diameter of the first intermediate portion.
In another embodiment, an introducing apparatus is provided which includes an elongate tubular sheath extending from a sheath proximal end to a sheath distal end. The sheath has a bore sized to receive a dilator therethrough. The sheath further includes at least one tab extending away from a longitudinal axis of the sheath. The dilator extends from a dilator proximal end to a dilator distal end. The introducing apparatus further includes a needle disposed within the dilator. The needle extends from a needle proximal end to a needle distal end and has an intermediate portion therebetween. At least a portion of the needle is flexible. The needle distal end is optionally echogenic.
Several options for the introducing apparatus are as follows. For example, in one option, the sheath is separable without damage to an instrument inserted therethrough. In another option, the needle distal end is more flexible than the dilator. In yet another option, the needle distal end has the same or less of flexibility as the dilator.
Further options include a valve coupled with the sheath. In another option, the dilator includes a catch sized and shaped to prevent re-extension of the needle. In yet another option, the introducing apparatus includes a locking mechanism configured to temporarily lock the sheath with the dilator. The dilator, in another option, further includes a blood flashback chamber and a gas permeable filter. In one option, the intermediate portion of the dilator is further defined by first and second dilator intermediate portions, and the dilator first intermediate portion has a greater outer diameter than an outer diameter of the dilator distal end, and the dilator second intermediate portion has a greater outer diameter than the outer diameter of the first intermediate portion.
A method is provided which includes disposing a needle within a dilator, where at least a portion of the needle is more flexible than the dilator. The method further includes retractably coupling a needle with a dilator, the dilator extending to a dilator distal end, where the needle extends to a needle distal end and the needle distal end extends beyond the dilator distal end. The method further includes disposing the needle and dilator within a sheath to form an introducing apparatus, and inserting the introducing apparatus into a body.
Several options for the method are as follows. For example, in one option, the method further includes retracting the needle within the dilator, and removing the needle and the dilator from the sheath. In another option, the method further includes preventing re-extension of the needle from the dilator. In yet another option, the method further includes removing the dilator and needle from the sheath, inserting an instrument through the sheath, and separating the sheath from the instrument without damage to the instrument. A valve is coupled with the sheath in another option.
The introducing apparatus beneficially provides a safety introducer, which allows for the needle to be safely retracted within the dilator after its use, and optionally prevents re-use of the same needle, for example on another patient.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.